Lutathera Approved in the European Union

AAA announced on September 29, 2017 that the European Commission (EC) has approved the marketing authorization of lutetium (177Lu) oxodotreotide* (Lutathera®) for “the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.” This approval allows for the marketing of lutetium (177Lu) oxodotreotide* (Lutathera®) in all 28 European Union member states, as well as Iceland, Norway and Liechtenstein. A New Drug Application is currently under review by the US Food and Drug Administration. The Prescription Drug User Fee Act (PDUFA) action date is January 26, 2018.Click here to read the company press release or here to read the EU approval.